US20070027533A1 - Cardiac valve annulus restraining device - Google Patents

Abstract

A catheter based system for treating mitral valve regurgitation includes a restraining device having a flexible member, a plurality of movable anchor members attached to the outer surface of the flexible member, and an adjustment filament attached to the ends of the flexible member. One embodiment of the invention includes a method for attaching a flexible restraining device to the annulus of a mitral valve, and adjusting the length of the adjustment filament attached to the flexible member of the restraining device, thereby reshaping the mitral valve annulus so that the anterior and posterior leaflets of the mitral valve close during ventricular contraction.

Description

TECHNICAL FIELD
• This invention relates generally to medical devices for treating mitral valve regurgitation, and particularly to a cardiac valve annulus restraining system and method of using the same.
BACKGROUND OF THE INVENTION
• Heart valves, such as the mitral, tricuspid, aortic and pulmonic valves, are sometimes damaged by disease or by aging, resulting in problems with the proper functioning of the valve. Heart valve problems take one of two forms: stenosis, in which a valve does not open completely or the opening is too small, resulting in restricted blood flow; or insufficiency, in which blood leaks backward across a valve when it should be closed. Valve replacement may be required in severe cases to restore cardiac function. In common practice, repair or replacement requires open-heart surgery with its attendant risks, expense, and extended recovery time. Open-heart surgery also requires cardiopulmonary bypass with risk of thrombosis, stroke, and infarction.
• Mitral valve insufficiency results from various types of cardiac disease. Any one or more of the mitral valve structures, i.e., the anterior or posterior leaflets, the chordae, the papillary muscles or the annulus may be compromised by damage from disease or injury, causing the mitral valve insufficiency. In cases where there is mitral valve insufficiency, there is some degree of annular dilatation resulting in mitral valve regurgitation. Mitral valve regurgitation occurs as the result of the leaflets being moved away from each other by the dilated annulus. Thus, without correction, the mitral valve insufficiency may lead to disease progression and/or further enlargement and worsening of the insufficiency. In some instances, correction of the regurgitation may not require repair of the valve leaflets themselves, but simply a reduction in the size of the annulus. A variety of techniques have been used to reduce the diameter of the mitral annulus and eliminate or reduce valvular regurgitation in patients with incompetent valves.
• Current surgical procedures to correct mitral regurgitation in humans include a number of mitral valve replacement and repair techniques. Valve replacement can be performed through open-heart surgery, open chest surgery, or percutaneously. The native valve is removed and replaced with a prosthetic valve, or a prosthetic valve is placed over the native valve. The valve replacement may be a mechanical or biological valve prosthesis. The open chest and percutaneous procedures avoid opening the heart and cardiopulmonary bypass. However, the valve replacement may result in a number of complications including a risk of endocarditis. Additionally, mechanical valve replacement requires subsequent anticoagulation treatment to prevent thromboembolisms.
• As an alternative to valve replacement, various valve repair techniques have been used including quadrangular segmental resection of a diseased posterior leaflet, transposition of posterior leaflet chordae to the anterior leaflet, valvuloplasty with plication and direct suturing of the native valve, substitution, reattachment or shortening of chordae tendinae, and annuloplasty in which the effective size of the valve annulus is contracted by attaching a prosthetic annuloplasty ring to the endocardial surface of the heart around the valve annulus. The annuloplasty techniques may be used in conjunction with other repair techniques. Annuloplasty rings are sometimes sutured along the posterior mitral leaflet adjacent to the mitral annulus in the left atrium. The rings either partially or completely encircle the valve, and may be rigid, or flexible but non-elastic. All of these procedures require cardiopulmonary bypass, though some less, or minimally invasive techniques for valve repair and replacement are being developed.
• Although mitral valve repair and replacement can successfully treat many patients with mitral valve insufficiency, techniques currently in use are attended by significant morbity and mortality. Most valve repair and replacement procedures require a thoracotomy, to gain access to the patient's thoracic cavity. Surgical intervention within the heart frequently requires isolation of the heart and coronary blood vessels from the remainder of the arterial system and arrest of cardiac function. Open chest techniques with large sternum openings are used. Those patients undergoing such techniques often have scarring retraction, tears or fusion of valve leaflets, as well as disorders of the subvalvular apparatus.
• Recently, other surgical procedures have been provided to reduce the mitral valve annulus using a less invasive surgical technique. According to this method, a prosthesis is transvenously advanced into the coronary sinus and deployed within the coronary sinus to reduce the diameter of the mitral valve annulus. The prosthesis then undergoes a change within the coronary sinus that causes it to assume a reduced radius of curvature, and as a result, to reduce the circumference of the mitral valve annulus. This may be accomplished in an open procedure or by percutaneously accessing the venous system by one of the internal jugular, subclavian or femoral veins.
• While the coronary sinus implant provides a less invasive treatment alternative, the placement of the prosthesis within the coronary sinus may be problematic for a number of reasons. Sometimes the coronary sinus is not accessible. The coronary sinus on a particular individual may not wrap around the heart far enough to allow enough encircling of the mitral valve. Also, leaving a device in the coronary sinus may result in the formation of thrombus, which may break off and pass into the right atrium, right ventricle and ultimately the lungs causing a pulmonary embolism. Another disadvantage is that the coronary sinus is sometimes used for placement of a pacing lead, which may be precluded with the placement of the prosthesis in the coronary sinus.
• Therefore, it would be desirable to provide a method and device for reducing cardiac valve regurgitation that use minimally invasive surgical techniques, and would overcome the limitations and disadvantages inherent in the devices described above.
SUMMARY OF THE INVENTION
• One aspect of the present invention provides a system for treating mitral valve regurgitation comprising a delivery catheter and a flexible restraining device. The restraining device comprises a flexible member having a plurality of anchor members, and adjustment members attached to the end portions of the flexible member. The restraining device has an elongated essentially linear configuration for catheter delivery to a location adjacent a mitral valve annulus and an arcuate configuration, which it assumes after it is deployed from a delivery catheter. When the restraining device is deployed from the delivery catheter, the barbs move from a delivery position to a deployment position and engage with the mitral valve annulus. Using the adjustment member, the radius of the flexible restraining members is adjusted causing a corresponding change in the shape of the mitral valve annulus.
• Another aspect of the invention provides a device for treating mitral valve regurgitation. The device includes a flexible restraining member having a plurality of anchor members extending from the flexible restraining member and at least one adjustment member attached to the end portions of the flexible restraining member. When the device is deployed from a delivery catheter, the barbs move from a delivery position to a deployment position and engage the annulus of the mitral valve. The radius of the flexible restraining member can then be adjusted via the adjustment members, causing the shape of the mitral valve annulus to change, and regurgitation to be reduced.
• Another aspect of the invention provides a method for treating mitral valve regurgitation. The method comprises using a catheter to deliver a flexible restraining device having shape-memory barbs adjacent to a location adjacent a mitral valve, deploying the flexible restraining device from the distal tip of the catheter, and moving the barbs from a delivery position to a deployment position in response to the deployment of the flexible device from the catheter. The method further comprises positioning the flexible device against the annulus of the mitral valve, inserting the anchor members into the annulus, and altering the radius of an arcuate portion of the flexible member. The mitral valve annulus is reshaped in response to the altering of the radius of the arcuate portion of the flexible member.
• The present invention is illustrated by the accompanying drawings of various embodiments and the detailed description given below. The drawings should not be taken to limit the invention to the specific embodiments, but are for explanation and understanding. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims and equivalents thereof. The drawings are not to scale. The foregoing aspects and other attendant advantages of the present invention will become more readily appreciated by the detailed description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a cross sectional schematic view of a heart showing the location of the mitral valve;
• FIG. 2 is a view of a flexible restraining device having a flexible member and movable barbs in a deployment position, in accordance with the present invention;
• FIG. 3 is a view of a flexible restraining device having movable barbs in a delivery position, in accordance with the present invention;
• FIG. 4 is a view of a flexible restraining device in an elongated delivery configuration, in accordance with the present invention;
• FIG. 5 is a side view of a flexible restraining device in an elongated configuration inside the distal portion of a delivery catheter, in accordance with one aspect of the invention;
• FIG. 6 is a schematic view illustrating the placement of the flexible restraining device adjacent to the mitral valve, in accordance with one aspect of the invention;
• FIG. 7 is a schematic view of a delivery system for the flexible restraining devices, in accordance with one aspect of the invention;
• FIG. 8 is a view of a wireform in an elongated configuration, in accordance with one aspect of the invention;
• FIG. 9 is a side view of a delivery catheter for delivering a wireform adjacent to the mitral valve, in accordance with one aspect of the invention;
• FIG. 10 is a flow diagram of a method of treating mitral valve regurgitation in accordance with one aspect of the invention.
DETAILED DESCRIPTION
• Throughout this specification, like numbers refer to like structures.
• Referring to the drawings,FIG. 1 shows a cross-sectional view ofheart1 havingtricuspid valve2 andtricuspid valve annulus3.Mitral valve4 is adjacentmitral valve annulus5.Mitral valve4 is a bicuspid valve havinganterior cusp7 andposterior cusp6.Anterior cusp7 andposterior cusp6 are often referred to, respectively, as the anterior and posterior leaflets.
• FIG. 2 portrays aflexible restraining device100 for treating mitral valve regurgitation.Restraining device100 includes aflexible member102 that is depicted in the figure in an arcuate shape that the member will assume upon delivery to a location adjacent a mitral valve.Flexible member102 is made of a flexible, biocompatible material that has “shape memory” so thatflexible member102 can be extended into an elongated configuration and inserted into a delivery catheter, but will assume a curved shape and dimensions when deployed adjacent to the mitral valve annulus. In one embodiment of the invention,flexible member102 comprises nitinol, a biocompatible material that givesflexible member102 the needed flexibility and shape memory. Fabrication offlexible member102 may include chemical machining, forming or heat setting of nitinol. In addition, the surface offlexible member102 should be hemocompatible, and cause minimal blood clotting or hemolysis when exposed to flowing blood. In one embodiment of the invention,flexible member102 comprises a flexible, nitinol ring with a cover. In one embodiment, the cover is composed of a polyester fiber. Dacron®, polyester fiber (E.I. Du Pont De Nemours & Co., Inc.) is a material known in the art to have the necessary hemocompatible properties and may be used in the cardiovascular system.
• The size and shape offlexible member102 are selected to fit the configuration of the mitral valve annulus. In one embodiment of the invention,flexible member102 is circular in shape except for asmall gap104.
• Extending from each of ends106 and108 offlexible member102 areflexible adjustment members110. In one embodiment of the invention, theadjustment members110 are firmly attached to ends106 and108 offlexible member102 and comprise a filament, string, wire, cord or cable. In another embodiment of the invention,flexible member102 comprises a hollow flexible tube andadjustment member110 is a single wire extending through the interior lumen offlexible member102, and protruding from ends106 and108 as shown inFIG. 2. In either embodiment,adjustment members110 are used to draw ends106 and108 offlexible member102 toward each other, and reshape restrainingdevice100 by reducinggap104, and changing the radius offlexible member102. The ends ofadjustment wire110 may then be twisted around each other to maintaingap104 at a reduced size. In other embodiments in whichadjustment member110 comprises a filament or other highly flexible material, the ends ofadjustment member110 are drawn toward each other and knotted, or held in place with a locking assembly, such as a clamp lock, or any other appropriate device.
• A plurality of anchor members, comprising barbs orprongs112, are disposed about the exterior surface offlexible member102, and are used to attachflexible member102 to the mitral valve annulus. In one embodiment of the invention,anchor members112 are formed by laser cutting the wall offlexible member102 in such a manner as to create sharp pointed portions in a plurality of locations. These sharp pointed portions may then be shaped into anchoringbarbs112, and then manipulated so that they are oriented at an angle of 45-90 degrees in relation to the surface offlexible member102, and heat set in this open position, as seen inFIG. 2. However,anchor members112 are flexible, and may be pressed back into the planer surface offlexible member102 to assume a closed position as shown inFIG. 3. In this closed position,anchor members112 form part of the smooth exterior surface offlexible member102, and facilitate delivery ofdevice100 via catheter.
• Flexible member102 can be transformed from its curved, nearly circular configuration (FIG. 2, 3) into an elongated, substantially linear configuration (FIG. 4). The two ends106,108 may be moved in opposite directions untildevice100 is in an elongated, substantially linear configuration. Becauseflexible member102 comprises a shape-memory material, such as nitinol,device100 will spontaneously revert to an unconstrained, flexible or curved configuration (FIG. 2) when free to do so.
• FIG. 5 is a side view of the distal portion ofsystem500 for treating mitral valve regurgitation using minimally invasive surgical techniques, in accordance with the present invention.Flexible restraining device100 is contained within asheath502 forming a delivery chamber in the distal portion ofdelivery catheter504.Delivery catheter504 is flexible, and configured so that it can be inserted into the cardiovascular system of a patient. Such catheters are well known in the art and are, for example, between 5 and 12 French in diameter. Appropriate catheters are made of flexible biocompatible materials such as polyurethane, polyethylene, nylon and polytetrafluoroethylene (PTFE). In order to facilitate passage through the vascular system,distal sheath502 may have greater lateral flexibility than the tubular body ofcatheter504. In one embodiment of the invention, an inflatable balloon is attached to the distal portion ofcatheter504, and connected by a lumen to a reservoir of liquid at the proximal end ofcatheter504.
• Flexible member102 of restrainingdevice100 is opened to its elongated configuration, andanchor members112 are in the closed, delivery position, forming a smooth exterior surface, as shown inFIG. 4.Restraining device100 is then placed within the lumen ofcatheter504 near catheterdistal tip506. Within the lumen ofcatheter504, and proximal to restrainingdevice100 is a deployment device, such asdelivery member508. Thedelivery member508 is made from a flexible material and it is used to deploy restrainingdevice100 by pushing it from catheterdistal tip506. In the depicted embodiment, the delivery member is a hollow member having an enlarged end portion that is adapted such that an end of the restraining device can fit therein during delivery and the be easily deployed therefrom. In the depicted embodiment, the adjustment members extending from the ends of the restraining device are routed into the delivery member during deployment of the restraining device. After restrainingdevice100 is deployed, thedelivery member508 may be withdrawn fromcatheter504. In one embodiment of the invention, the interior surface ofcatheter504 is coated with a lubricious material such as silicone, polytetrafluoroethylene (PTFE), or a hydrophilic coating. The lubricious interior surface ofcatheter504 facilitates the longitudinal movement ofdelivery member508 and deployment of restrainingdevice100.
• In another embodiment of the invention,sheath502 is retractable (not shown), as is well known in the art.Sheath502 is retracted by the physician operator to deploydevice100 fromdelivery catheter504. In this embodiment,delivery member508 or a holding means may be used to maintaindevice100 in a fixed position near catheterdistal tip506 untildevice100 is deployed from the catheter.
• To deliver restrainingdevice100 adjacent to mitral valve4 (FIG. 1),distal tip506 ofdelivery catheter504 containingdevice100 is inserted into the vascular system of the patient. As shown inFIG. 6,catheter504 may be inserted into the subclavian vein, through superior vena cava8, and intoright atrium9. Alternatively,catheter tip506 may be inserted through the femoral vein into the common iliac vein, throughinferior vena cava10, and intoright atrium9. Next,transeptal wall11 betweenright atrium9 and leftatrium12 is punctured with a guide wire or other puncturing device anddistal tip506 ofdelivery catheter504 is advanced through the septal perforation and intoleft atrium12 and placed in proximity toannulus5 ofmitral valve4. Another possible delivery path would be through the femoral artery into the aorta, through the aortic valve into the left ventricle, and then through the mitral valve intoleft atrium12. Yet another possible path would be through the left or right pulmonary vein directly intoleft atrium12. The placement procedure, using any of these vascular routes, is preferably performed using fluoroscopic or echocardiographic guidance.
• While the devices described herein can be delivered to a position adjacent a mitral valve annulus in a manner described above, other delivery systems and means can also be used.FIGS. 7 and 8 illustrate an embodiment of adelivery system700 having a wireform that can be used as a guide for delivering at least one embodiment of the annulus restraining devices described herein.FIG. 7 illustrates an approach route in which catheters and/or guidewires are inserted into the femoral vein and passed through the common iliac vein,inferior vena cava10, and intoright atrium9. Regardless of the route toright atrium9,atrial septum11 can be punctured with a guide wire or other puncturing device so that the annulus restraining device can be positioned inleft atrium12. In one embodiment of a delivery system for the devices, a puncture catheter, as is well known in the art, can be configured and used to pierce the wall ofatrial septum11. The delivery systems may also include a dilator catheter for providing a larger diameter pathway for delivering annulus reduction delivery system.
• Referring toFIG. 7,delivery system700 compriseswireform705 having pre-shapedannular portion710,proximal portion740 andstabilizer portion750.Wireform705 may be composed of biocompatible metal, polymer or combinations thereof. In one embodiment,wireform705 is pre-shaped and sized to fit the anatomy of a particular patient. In one embodiment, pre-shapedannular portion710 comprises nitinol. In another embodiment, pre-shapedannular portion710 comprises a section of tubular braid, either with or without a central monofilament core extending there through. Pre-shapedannular portion710 provides a rail or guide for positioning an annulus reduction delivery system or device around and within theannulus5 ofmitral valve4.FIG. 8 illustrateswireform705 in a straight configuration as it may appear either during manufacture and beforeannular portion710 is shaped, or aswireform705 may temporarily appear during delivery to a cardiac valve through a delivery catheter.
• Wireform stabilizer portion750 extends distally from pre-shapedannular portion710 and, in one embodiment, extends through themitral valve4 and intoleft ventricle14. Astabilizer portion750 traverses leftventricle14 to rest on or near the apex ofleft ventricle14 adjacentpapillary muscles13 to provide stability for wireformannular portion710 during placement of an annulus restraining device.Stabilizer portion750 may comprise a material that is relatively soft atdistal tip760 forming a pigtail or spiral shape as is known in the art. In another embodiment, stabilizingportion750 extends fromannular portion710 in a superior direction to rest against an upper portion ofleft atrium12 to provide stability. In another embodiment,wireform705 does not include stabilizingportion750.Delivery system700 provides a pathway to and aroundmitral valve annulus5 for delivering and positioning an annulus restraining device for implantation.
• FIG. 9 illustratesdelivery catheter900 for deliveringwireform705 having a pre-shapedannular portion710.Delivery catheter900 includesproximal section910, restrainingsection920 and softdistal tip930.Delivery catheter900 comprises a flexible, biocompatible polymeric material such as polyurethane, polyethylene, nylon, or polytetrafluroethylene (PTFE). Additionally, restrainingsection920 has sufficient stiffening capabilities to maintain pre-shapedannular portion710 in a straightened delivery configuration. In one embodiment, a braided metallic or polymeric material is embedded in the wall of restrainingsection920. In another embodiment metallic or polymeric rods are embedded in the wall of restrainingsection920.
• In operation,wireform705 is inserted intodelivery catheter900.Delivery catheter900 is then advanced to the target valve as described above. In one embodiment,distal end935 is positioned withinleft atrium12 andwireform705 is pushed out ofdelivery catheter900 to formdelivery system700 as seen inFIG. 7. In another embodiment,distal end935 is advanced throughmitral valve4 and positioned adjacentpapillary muscle13.Delivery catheter900 is then retracted whilewireform705 is held stationary. Asdelivery catheter900 is retracted,delivery system700 forms as seen inFIG. 7.
• Oncedelivery system700 is placed as seen inFIG. 7,delivery system700 may be used to guide a suitable delivery catheter forannulus restraining device100 tomitral valve annulus5.
• FIG.10 is aflowchart illustrating method1000 for treating mitral valve regurgitation, in accordance with one aspect of the invention. As described inFIG.6, the distal tip ofdelivery catheter504 containingflexible restraining device100 is advanced through the vascular system of the patient, passed throughright atrium9 and intoleft atrium12, adjacent to mitral valve annulus5 (Block1002). If a device such asdelivery system700 is used,wireform705 is first delivered adjacent to the mitral valve of the patient using a delivery catheter such ascatheter900. Asdelivery system700 is extruded fromcatheter900,delivery system700 takes the form seen inFIG. 7, and provides a guide for a delivery catheter suitable forannulus restraining device100, such asdelivery catheter504.
• Next, the restraining device is deployed adjacent tomitral valve annulus5 from the delivery catheter (Block1004). If a catheter such ascatheter504 is used, theflexible tip506 is moved along the surface ofmitral valve annulus5, and used to direct the placement of restrainingdevice100. Ifdelivery system700 is used, the distal tip of a suitable catheter is guided alongwireform705. In either case, a deployment device, such asdelivery member508 withindelivery catheter504 is used to deploy restrainingdevice100 by pushing it fromdistal tip506 ofdelivery catheter504 and layingflexible restraining device100 alongmitral valve annulus5. In yet another embodiment,sheath502 is retracted to deploy restrainingdevice100.
• Restraining device100 is positioned so thatanchor members112 on the surface of restrainingdevice100 are facing the surface ofmitral valve annulus5. As restrainingdevice100 is extruded fromdistal tip506 ofdelivery catheter504,flexible member102 ofdevice100 will assume a curved, nearly circular configuration commensurate withmitral valve annulus5. Inaddition anchor members112 assume a deployment configuration, in which they extend away from the surface offlexible member102 at a predetermined angle (Block1006).
• In one embodiment of the invention, an inflatable balloon is then extended fromdistal tip506 ofdelivery catheter504 immediately adjacent to the surface of restrainingdevice100. The balloon may either be attached todistal portion502 ofdelivery catheter504, or it may be mounted on a separate catheter that is passed throughdelivery catheter504. In either case, the balloon is inflated against restrainingdevice100 in order to pushflexible member102 against the surface ofmitral valve annulus5, with sufficient force to causebarbs112 to penetratemitral valve annulus5, and to anchor restrainingdevice100 securely in place (Block1008).
• Once restrainingdevice100 is secured tomitral valve annulus5 byanchor members112,adjustment member110 is manipulated so that the radius offlexible member102 and the underlying mitral valve annulus are reduced by the desired amount (Block1010). In one embodiment of the invention,flexible rod508, used to deploy the restrainingdevice100 is withdrawn from the catheter, forceps are advanced through the catheter, and the tip of the forceps is placed adjacent to restrainingdevice100, which is attached tomitral valve annulus5. Next, the forceps are used to grasp theadjustment elements110, which in this embodiment are wires.Adjustment wires110 are drawn together, and twisted around each other, causing the length ofadjustment members110 to be reduced, and ends106 and108 offlexible member102 to be drawn toward each other, reducing the size ofgap104. In this embodiment,adjustment wires110 remain twisted around each other, and maintaingap104 at a fixed size. In another embodiment, a locking assembly, such as a clamp lock or any other appropriate device may be used to maintain the length ofadjustment members110. By drawing ends106 and108 offlexible member102 together, the circumference offlexible member102 is reduced, and, because restrainingdevice100 is securely fastened toannular ring5 of mitral valve4 (Block1012), the circumference ofannular ring5 is reduced correspondingly. The circumference of mitral valveannular ring5 is modified sufficiently so that anterior andposterior leaflets7 and6 close during ventricular contraction, and regurgitation of blood is reduced (Block1012). Improvement in the valve closure can be evaluated by checking for decreased pressure inleft atrium12. Finally,delivery catheter504 is withdrawn from the body of the patient.
• While the invention has been described with reference to particular embodiments, it will be understood by one skilled in the art that variations and modifications may be made in form and detail without departing from the spirit and scope of the invention.

Claims (20)

1. A system for treating mitral valve regurgitation, the system comprising:

a catheter;

a flexible restraining device having a plurality of anchor members extendable therefrom;

the anchor members being integrally formed with or fixedly attached to the flexible restraining device;

the anchor members shaped for penetration into the annulus of a mitral valve

the anchor members being movable from a delivery configuration to a deployment configuration; and

an adjustment member extending from end portions of the flexible restraining device.

2. The system ofclaim 1 wherein the flexible restraining device has an elongated, essentially linear configuration and an arcuate configuration;

the flexible restraining device has an inner surface and an outer surface and the anchor members are positionable in a catheter delivery configuration, in which the anchor members are parallel to the outer surface of the flexible restraining device; and

the anchor members are positionable in a deployment configuration, in which the anchor members extend radially from flexible restraining device and when the device is deployed from a catheter the anchor members extend to the deployment configuration.

3. The system ofclaim 1 wherein the flexible restraining device and anchor members comprise a shape memory alloy.

4. The system ofclaim 1 wherein the flexible restraining device and anchor members comprise nitinol.

5. The system ofclaim 1 further comprising means for seating the flexible restraining device against the annulus of a mitral valve and implanting the anchor members into the annulus.

6. The system ofclaim 1 wherein the catheter comprises:

an outer sheath;

a delivery chamber within the sheath at a distal end of the catheter; and

a deployment device positioned within the delivery chamber, wherein when the system is delivered to a location adjacent to a mitral valve, the flexible restraining device is deployed from the delivery chamber and positioned in a supra-annular position adjacent to the annulus of the mitral valve.

7. The system ofclaim 6 further wherein the catheter further comprises an inflatable balloon attached thereto and when the balloon is inflated, the flexible restraining device is seated against the annulus of the mitral valve.

8. The system ofclaim 1 wherein the adjustment member is selected from the group consisting of a string, a wire, a cord, a filament, and a cable.

9. The system ofclaim 8 wherein the flexible restraining device is a generally tubular member and the adjustment member is routed through the restraining device such that the ends of the adjustment member extend from the ends of the restraining device, and wherein when the restraining device is in an arcuate configuration, the adjustment member may be used to draw the ends of the flexible restraining device toward each other and maintain the ends of the restraining device in a fixed position.

10. A device for treating mitral valve regurgitation comprising:

a flexible restraining device having a plurality of anchor members extending therefrom;

the anchor members being integrally formed with or fixedly attached to the flexible restraining device;

the anchor members being movable from a delivery configuration to a deployment configuration; and

an adjustment member extending from end portions of the flexible restraining device.

11. The device ofclaim 10 wherein the flexible restraining device has an inner surface, an outer surface, an arcuate configuration and an elongated, essentially linear configuration;

the anchor members are positionable in a catheter delivery configuration, in which the anchor members lie on the outer surface of the flexible restraining device; and

the anchor members are positionable in a deployment configuration, in which the anchor members extend radially from flexible restraining device and when the device is deployed from a catheter the anchor members extend to the deployment configuration.

12. The device ofclaim 10 wherein the adjustment member is selected from the group consisting of a string, a wire, a cord, a filament, and a cable.

13. The device ofclaim 10 wherein the flexible restraining device is a generally tubular member and the adjustment member is routed through the restraining device such that the ends of the adjustment member extend from the ends of the restraining device, and wherein when the restraining device is in an arcuate configuration, the adjustment member may be used to draw the ends of the flexible restraining device toward each other and maintain the ends of the restraining device in a fixed position.

14. The device ofclaim 13 further comprising means for securing the ends of the adjustment members such the ends of the restraining device can be maintained in a fixed position.

15. The device ofclaim 10 wherein the flexible restraining device and anchor members comprise a shape memory alloy.

16. The system ofclaim 12 wherein the flexible restraining device and anchor members comprise nitinol.

17. A method of treating mitral valve regurgitation, the method comprising:

delivering a flexible restraining device, having shape-memory anchor members, to a location adjacent a mitral valve via a catheter;

deploying the flexible restraining device from the distal tip of the catheter thereby causing the flexible restraining device to assume an arcuate configuration;

moving the anchor members from a delivery to a deployment configuration responsive to the deployment of the flexible restraining device;

positioning the flexible restraining device against an annulus of the mitral valve;

inserting the anchor members into the annulus;

altering the shape of the flexible restraining device by altering the radius of the arcuate configuration; and

reshaping the annulus in response to the altering of the radius of the arcuate configuration the flexible restraining device.

18. The method ofclaim 17 wherein inserting the shape memory anchor members into the annulus further comprises inflating a balloon to exert force on the flexible ring, and causing the anchor members to penetrate the annulus.

19. The method ofclaim 17 wherein altering the radius of an arcuate configuration of the flexible restraining device further comprises drawing the ends of the device toward each other when the device is in the arcuate configuration.

20. The method ofclaim 17 wherein reshaping the annulus of the mitral valve reduces mitral valve regurgitation.

Images